Edoxaban Use May be Safe for Patients Undergoing A-fib Ablation
WASHINGTON, DC—At the ACC.17 Scientific Session, Jan Steffel, from the University Heart Center, Zurich, Switzerland, and colleagues presented that the use of edoxaban may be safe in the context of atrial fibrillation (AF) ablation.
A growing amount of patients receiving novel anticoagulants (NOACs) are undergoing AF ablation procedures but "experience regarding the safety of edoxaban in this context is limited," said Steffel. The team of researchers studied the outcome of patients included in the double-blind, randomized ENGAGE AF-TIMI 48 (Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48) trial who were undergoing AF ablation.
In the exploratory analysis, 196 total AF ablation procedures were performed in 172 patients. The patients tended to be younger (P<0.0001), more likely to be paroxysmal (P<0.0001), more frequently had a CHADS2 score ≤3 (P=0.0011), and most frequently were from North America (P<0.0001). After the majority of ablations, the study drug was interrupted for ≤10 days in 88 patients and for ≤3 days in 35 patients.
"During the first 30 days after the ablation procedure, one ischemic stroke was observed in the warfarin group and none in the high-dose edoxaban regimen (HDER) or low-dose edoxaban regimen (LDER)," Steffel reported. Also, three clinically relevant non-major bleeding events were seen in the warfarin group vs. 1 major bleed in the HDER group and 1 minor bleed in the LDER groups. All of the bleeding events happened among patients with <10 days study drug interruption but no ischemic events or deaths were seen in these patients.
Findings from this analysis indicated a low risk of ischemic or bleeding events during the first 30 days post-ablation, separate from the allocated treatment group. Some of the study's limitations included lack of granularity regarding procedural management, use of heparin during the procedure, and a small cohort size that underwent ablation.
"These findings indicate for the first time that the use of edoxaban may be safe in the context of AF ablation," noted Steffel. "A dedicated study to address the safety and efficacy of transcatheter AF ablation on continued edoxaban is underway."